ovel treatment for pollen-food allergy syndrome using hypoallergenic polle
- Conditions
- pollen-food allergy syndrome
- Registration Number
- JPRN-jRCTs031230008
- Lead Sponsor
- Komatsuzaki Keiko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 5
1) Patients who are positive for alder or white birch-specific IgE and exhibit oral allergy symptoms due to raw apples
2) Age between 18 and 64 at the time of obtaining consent
3) Subjects who have obtained written informed consent of their own free will after sufficient understanding to participate in this research.
4) Those who can go to Tokyo Medical and Dental University Hospital / Ikebukuro Otani Clinic
1)Patients with a history of anaphylaxis to raw apples
2)Patients who have undergone allergen immunotherapy with Betulaceae pollen in the past
3) Subjects who performed a skin prick test with birch pollen-galactomannan conjugate ointment before the start and compared with the positive control, the wheal diameter was 1/2 or more or 3 mm or more larger than the wheal diameter of the negative control.
4) Patients who have undergone or are undergoing treatment with biological agents such as anti-IgE antibody, anti-IL-5 antibody, anti-IL-4a antibody, anti-TSLP antibody
5)Patients with suspected infectious disease within 4 weeks before enrollment
6) Patients with allergic rhinitis-like diseases such as acute rhinitis, suspected acute/chronic sinusitis, and eosinophilic sinusitis
7)Patients who received treatment with non-topical steroids or immunosuppressants within 4 weeks before enrollment
8) Patients with uncontrolled bronchial asthma, patients undergoing treatment or follow-up for malignant disease
9) Women who are pregnant or may become pregnant
10) Lactating women
11) Patients participating in other clinical trials or clinical studies at the time of enrollment
12) In addition, patients who are judged inappropriate by the principal investigator or researcher to conduct this research safely
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Raw apple oral challenge intake threshold and VASmm<br>Wheal diameter of skin prick test with raw apple and birch extract
- Secondary Outcome Measures
Name Time Method Secondary efficacy endpoints<br>Serum birch-specific IgE, IgG, IgG1, IgG4, serum Bet v 1-specific IgE, IgG, IgG4 Saliva birch-specific IgA, IgG<br>Total IgE, peripheral blood eosinophil count<br>Nasal eosinophil count